Pull out Strength of Dual Outer Diameter Pedicle Screws Compared to Uncemented and Cemented Standard Pedicle Screws: A Biomechanical in vitro Study

Objective: To analyze the potential of the dual outer diameter screw and systematically evaluate the pull-out force of the dual outer diameter screw compared to the uncemented and cemented standard pedicle screws with special regard to the pedicle diameter and the vertebra level. Methods: Sixty vertebrae of five human spines (T-6-L-5) were sorted into three study groups for pairwise comparison of the uncemented dual outer diameter screw, the uncemented standard screw, and the cemented standard screw, and randomized with respect to bone mineral density (BMD) and vertebra level. The vertebrae were instrumented, insertion torque was determined, and pull-out testing was performed using a material testing machine. Failure load was evaluated in pairwise comparison within each study group. The screw-to-pedicle diameter ratio was determined and the uncemented dual outer diameter and standard screws were compared for different ratios as well as vertebra levels. Results: Significantly increased pull-out forces were measured for the cemented standard screw compared to the uncemented standard screw (+689 N, P < 0.001) and the dual outer diameter screw (+403 N, P < 0.001). Comparing the dual outer diameter screw to the uncemented standard screw in the total study group, a distinct but not significant increase was measured (+149 N, P = 0.114). Further analysis of these two screws, however, revealed a significant increase of pull-out force for the dual outer diameter screw in the lumbar region (+247 N, P = 0.040), as well as for a screw-to-pedicle diameter ratio between 0.6 and 1 (+488 N, P = 0.028). Conclusions: For clinical application, cement augmentation remains the gold standard for increasing screw stability. According to our results, the use of a dual outer diameter screw is an interesting option to increase screw stability in the lumbar region without cement augmentation. For the thoracic region, however, the screw-to-pedicle diameter should be checked and attention should be paid to screw cut out, if the dual outer diameter screw is considered.